BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 7375728 · Received March 27, 2018

    Report

    Report Number
    3005075853-2018-08770
    Event Type
    Injury
    Date Received
    March 27, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THE POST-OPERATIVE BLEEDING ISSUE IDENTIFIED IN THE JOURNAL ARTICLE ARE RELATED TO ALLEGED DEFICIENCY WITH AN ETHICON DEVICE? WAS THE BLEEDING FROM THE STAPLE LINE OR OMENTUM?

    Description of Event or Problem · 1

    TITLE: A RANDOMIZED COMPARISON BETWEEN STAPLE-LINE OVERSEWING VERSUS NO REINFORCEMENT DURING LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY AUTHORS: OSAMA TAHA, MAHMOUD ABDELAAL, MOHAMED TALAAT, MOHAMED ABOZEID CITATION: OBES SURG. 2018; 28: 218 225. DOI: 10.1007/S11695-017-2835-Y THE AIM OF THIS SINGLE-CENTER RANDOMIZED STUDY WAS TO EVALUATE THE COMPLICATION RATES OF THE GASTRIC STAPLING ALONE VERSUS STAPLING WITH OVERSEWING INVAGINATION OF THE STAPLE LINE IN LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY (LSG). A TOTAL OF 400 PATIENTS (24 TO 43 YEARS OLD) WERE INCLUDED IN THE STUDY. OF WHICH, 200 PATIENTS UNDERWENT LSG WITHOUT REINFORCEMENT OF THE STAPLE-LINE (GROUP 1) AND 200 PATIENTS UNDERWENT REINFORCED LSG BY A SEROSEROSAL OVERSEWING ALONG THE ENTIRE STAPLE-LINE (GROUP 2). THE SLEEVE IS CREATED IN A STANDARD FASHION THROUGH THE 5-PORT TECHNIQUE AND USAGE OF FR 26 BOUGIES FOR CALIBRATIONS. THE GREATER OMENTUM WAS DISSECTED BY USING THE HARMONIC SCALPEL FROM 2 TO 4 CM PROXIMAL TO THE PYLORUS TO THE ANGLE OF HIS. IN GROUP 2, THE REMNANT GASTRIC TUBE WAS OVERSEWN BY INVAGINATION OF THE STAPLE LINE USING VICRYL 3-0 CONTINUOUS SEROSEROSAL SUTURES. IN GROUP 1, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-1), PROLONGED VOMITING (N-9) IN WHICH A PROGRESSIVE ENDOSCOPIC GASTRIC DILATATION WAS DONE IN 1 PATIENT, STAPLE-LINE LEAKAGE (N-1), AND STAPLE-LINE BLEEDING (N-18). IN GROUP 2, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-3), PROLONGED VOMITING (N-18) IN WHICH A SECONDARY SURGICAL INTERVENTION TO EVACUATE A LESSER CURVATURE HEMATOMA LAPAROSCOPICALLY WAS DONE IN 1 PATIENT, AND STAPLE-LINE BLEEDING (N-4). IT WAS CONCLUDED THAT OVERSEWING OF THE STAPLE LINE DURING LSG IS A NON-EXPANSIVE AND EASY METHOD TO DECREASE THE INCIDENCE AND SEVERITY OF THE POSTOPERATIVE BLEEDING. HOWEVER, IT IS TIME CONSUMING AND SHOULD BE PERFORMED BY EXPERIENCED SURGEONS TO AVOID THE COMPLICATIONS WHICH MAY OCCUR SECONDARY TO THE SEROSEROTOMY SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216604 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other